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Agent Gcp and the Bloody Consent Form: Informed Consent and Institutional Review Boards in Clinical Trials, for Beginner to Advanced, for Pharmaceutical and Medical Device Companies, Cros

Farb, Daniel, M.D./ Gordon, Bruce

1 valoraciones por Goodreads
ISBN 10: 1594910324 / ISBN 13: 9781594910326
Editorial: Universityofhealthcare, 2004
Nuevos Condición: Brand New Encuadernación de tapa blanda
Librería: Revaluation Books (Exeter, Reino Unido)

Librería en AbeBooks desde: 6 de enero de 2003

Cantidad: 1

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Precio recomendado: 499.95
Precio: EUR 739,09 Convertir moneda
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paperback/cd-rom edition. 67 pages. 8.80x6.00x0.30 inches. In Stock. N° de ref. de la librería 1594910324

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Título: Agent Gcp and the Bloody Consent Form: ...

Editorial: Universityofhealthcare

Año de publicación: 2004

Encuadernación: Paperback

Condición del libro:Brand New

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Agent GCP is THE way to learn FDA regulations. The exciting, suspenseful, and sometimes zany plot of a murder in a clinical trial is interweaved with interactivity and teaching of FDA regulations in an unforgettable manner. Subjects are modularized so that learners can take one subject out of sequence should they need to. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course consists of 9 smaller courses and a final exam and covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)--that is, the regulations of Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for anyone conducting clinical trials or informed consent outside of a clinical trial. Time estimate: 15-20 hours. 826 pages on CD. 67 pages in the manual. For convenience, the CD and the manual contain the text of relevant regulations. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.

From the Publisher:

4 star review from Foreword Reviews: The discovery, after World War II, of the Nazi doctors’ shocking experimentation on people caused the United States to pass laws requiring the ethical treatment of human subjects during experiments. This CD with accompanying manual is meant to teach doctors these laws.

UniversityofHealthCare is a company devoted to designing training CDs for health professionals. Dr. Farb provides the medical expertise. Mr. Gordon’s experience in writing stand-up routines for nationally known comics, and doing production work on "Dynasty" and "Love Boat," is evident throughout the CD.

The CD contains ten lessons, or "episodes." They are called episodes because each one advances the story of Dr. Michelle Coquette, the Director of Clinical Trials for Oncophrenics Pharmaceutical Corporation. Michelle, with the help of Agent GCP, discovers that there are problems with her company’s testing of its new antidepressant drug, Cheerasil. An informed consent form with blood on it is a tip-off that the researchers are not following proper procedures when obtaining consent from the study subjects.

The plot is skimpy, but it keeps the reader interested in learning the laws. The CD is a surprisingly fast and lively read. In addition to resembling an episode on a television show, each lesson is like a game show. Worked into the lessons are multiple choice questions about the laws. The questions are constructed in a fun way; there is usually one humorous wrong answer. It is entertaining to be able to interact with the computer. It makes it more likely that the reader will finish all the lessons and, hence, learn the laws.

The CD’s clip art and pictures are a little raw, but this adds to the zany game show effect. Michelle is presented in a way that could be construed as sexist. She has to flirt with the computers to get them to help her. Female readers may be annoyed by this, but it does add to the overall TV-show motif.

This CD is an entertaining way for doctors, pharmaceutical company scientists, and other researchers to learn about the laws governing such issues as informed consent and the role of Institutional Review Boards (IRBs) in clinical research.

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Legal entity name: Edward Bowditch Ltd
Legal entity form: Limited company
Business correspondence address: Exstowe, Exton, Exeter, EX3 0PP
Company registration number: 04916632
VAT registration: GB834241546
Authorised representative: Mr. E. Bowditch

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